Office of Clinical Research

• Study Start-Finish Guide

Study Start-Finish Guide

Do you have questions on how to start a clinical research study at Penn? Or how to close a study?

The Clinical Research Study Start – Finish guide will navigate you through the life cycle of a study.

The Start – Finish guide can help you navigate clinical research resources at Penn. This includes, but is not limited to:

• Protocol development
• Applications to the IRB, other Penn Reviewing Entities, and outside groups
• Regulatory compliance requirements
• Ongoing study resources
• Study close out procedures

The Start-to-Finish documents are intended to be used in conjunction with the Penn Manual.

• The Industry Sponsored Clinical Trial Guide gives an overview of the required steps for any given Industry Sponsored Clinical Trial.
   
• The In-House or Federally Funded Guide outlines the main steps for conducting studies that are either in-house funded (eg: supported by Departmental , University, or gift fund) or funded by a federal entity (eg: NIH, DOD, NSF, etc.).
   
• The Investigational New Drug (IND) study start to finish guide gives an overview of the steps necessary to conduct at study when a University of Pennsylvania faculty member is serving as the sponsor of the research study involving a drug, biologic, etc. 
   
• The Investigational Device Exemption (IDE) study start to finish guide provides an overview of the steps necessary to conduct a study when a University of Pennsylvania faculty member is serving as the sponsor of a research study involving a device. 

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Contact OCR with any questions you may have about the research approval or conduct process.